Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting

NCT03767790 | Completed FDA Device

• 1 other identifier: G180011-S001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized crossover clinical trial is to 1) assess the efficacy and safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in people with type 1 diabetes, and 2) assess the impact of different meal macronutrient content on glucose control when using AID and SAP.

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas; Hyperglycemia; Hypoglycemia; Nutrition

Outcome Measures

Primary Outcomes (1)

• Time in target glucose range

  Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system

  4 weeks

Secondary Outcomes (12)

• Postprandial glucose peak

  4 weeks

• Time to postprandial glucose peak

  4 weeks

• Postprandial Area Under the Curve

  4 weeks

• Postprandial time for glucose to return to baseline

  4 weeks

• Glucose < 70 mg/dL

  4 weeks

Other Outcomes (6)

• Total daily insulin use

  4 weeks

• Total basal insulin use

  4 weeks

• Total bolus insulin use

  4 weeks

Study Arms (2)

Automated Insulin Delivery

EXPERIMENTAL

Participants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting. During AID use, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.

Device: iAPS

SAP/PLGS

NO INTERVENTION

Participants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting. During these 2 weeks, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.

Interventions

iAPS DEVICE

The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.

Automated Insulin Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year.
• Using an insulin pump for at least 3 months at the time of screening. Insulin pump use includes use of automated features, to include predictive or threshold low-glucose suspend or hybrid closed-loop with without a Dexcom sensor.
• Familiarity and use of a carbohydrate ratio for meal boluses.
• Age ≥18.0 years old
• HbA1c \< 10.5%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 weeks of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
• For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• Willingness to switch home pump to PLGS or full manual mode if using hybrid closed-loop with an FDA approved system.
• Have an emergency contact living at home with the subject who will be available to be contacted by the study staff overnight in the event of an emergency.
• Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, to include having basic cooking equipment at home to prepare the study meals.
• Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.

You may not qualify if:

• Use of an unapproved closed-loop insulin delivery system within 2 weeks before screening or during the study is not allowed.
• Gastrointestinal disease such as celiac disease or multiple food allergies.
• Any form of gluten sensitivity or wheat allergy.
• Allergies to any form of nuts or ingredients present in the study meals (tomatoes etc).
• History of difficulty digesting food.
• Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
• Hemophilia or any other bleeding disorder
• One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months.
• One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months.
• Self-reported or clinically documented hypoglycemia unawareness.
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Harvard University: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (1)

• Deshpande S, Pinsker JE, Church MM, Piper M, Andre C, Massa J, Doyle Iii FJ, Eisenberg DM, Dassau E. Randomized Crossover Comparison of Automated Insulin Delivery Versus Conventional Therapy Using an Unlocked Smartphone with Scheduled Pasta and Rice Meal Challenges in the Outpatient Setting. Diabetes Technol Ther. 2020 Dec;22(12):865-874. doi: 10.1089/dia.2020.0022. Epub 2020 Oct 13.

  PMID: 32319791 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eyal Dassau, PhD

  John A. Paulson School of Engineering and Applied Sciences

  PRINCIPAL INVESTIGATOR

• David Eisenberg, MD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Jordan E Pinsker, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: January 3, 2019
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)